17 Feb 2021 07:00
Evgen Pharma plc
("Evgen" or the "Company")
Update on patient recruitment
STAR COVID-19 trial exceeds 100 patients
Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, announces that as of 16 February, a total of 102 patients had been recruited and randomised to the STAR trial ("SFX-01 Treatment for Acute Respiratory infections").
This Phase II/III trial is a randomised, placebo-controlled trial, sponsored by the University of Dundee and funded by the UK charity LifeArc. It is investigating whether the Company's lead asset, SFX-01, can reduce the severity, or prevent the onset of, acute respiratory distress syndrome ("ARDS") in patients with suspected COVID-19. Patients may be included in the study if they are infected with SARS-CoV-2 or another respiratory infections causing community-acquired pneumonia.
The trial design includes an assessment of safety and futility by a Data Safety and Monitoring Board ("DSMB") who will review unblinded data on the first 100 patients treated. In addition to the DSMB safety and futility assessment, Dundee University ("the Sponsor") has decided to review the top-level unblinded data in a preliminary assessment of possible efficacy. This may lead to adjustments to the design of the trial for remaining patients, including in patient numbers, and possibly early termination for either safety, futility or alternatively, strong efficacy. It is expected that this initial data will be available during the second quarter of calendar 2021.
The Sponsor has also requested that the DSMB review data from the first 60 patients solely for safety and this process will be starting shortly. The outcome of this is expected to be available in early Q2 2021.
Completion of recruitment to the STAR trial is anticipated at the end of 2021/Q1 2022, assuming there are no substantial changes in the total patients to be recruited.
Dr Huw Jones, CEO of Evgen, commented: "We are pleased with the recruitment progress in this trial and would again like to thank Professor James Chalmers and his colleagues at Dundee for their considerable efforts in a very challenging clinical environment. Randomising over 100 patients is an important milestone in this trial and takes us a step closer to receiving the initial data from the study. We look forward to further updating the market as we progress through this important trial.''
The information communicated in this announcement is inside information for the purposes of Article 7 of EU Regulation 596/2014.
Enquiries:
Evgen Pharma plc www.evgen.com | via Walbrook | |
Barry Clare, Chairman Dr Huw Jones, CEO |
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Richard Moulson, CFO |
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finnCap www.finncap.com | +44 (0)20 7220 0500 | |
Geoff Nash / Teddy Whiley (Corporate Finance) |
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Alice Lane (ECM) |
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Walbrook PR | +44 (0)20 7933 878 or evgen@walbrookpr.com | |
Paul McManus / Anna Dunphy | +44 (0)7980 541 893 / +44 (0)7876 741 001 | |
About Evgen Pharma plc
Evgen Pharma is a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases. The Company's core technology is Sulforadex®, a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane. The lead product, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin.
Clinical data from the Company's open-label Phase II STEM trial has shown that SFX-01 can halt the growth of progressing tumours in patients with oestrogen-positive (ER+) metastatic breast cancer, and in some cases significantly shrink the tumour, whilst causing very few side effects.
The Company commenced operations in January 2008 and has its headquarters at The Colony, Wilmslow, Cheshire, and its registered office is at the Liverpool Science Park, Liverpool. It joined the AIM market of the London Stock Exchange in October 2015 and trades under the ticker symbol EVG.
For further information, please visit: www.evgen.com